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Trial record 18 of 1728 for:    CARBON DIOXIDE AND dioxide

Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811522
Recruitment Status : Active, not recruiting
First Posted : January 22, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Mercy Health Ohio
Information provided by (Responsible Party):
North Eastern Ohio Gastroenterology and Endoscopy center

Tracking Information
First Submitted Date January 11, 2019
First Posted Date January 22, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
The reduction of post operational pain [ Time Frame: the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op. ]
Assessment of post operational pain will be made by the the horizontal assessment scale (HAS) for post operative pain. The survey will include the following questions.
  1. Mark your level of pain by drawing a horizontal line on the scale below.
  2. Rate the severity of your nausea by circling a number on the scale.
  3. Rate the severity of your bloating by circling a number on the scale.
  4. Rate the severity of your abdominal fullness by circling a number on the scale.
    • Note the scale was not provided given the limitation of characters.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03811522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy
Official Title Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy
Brief Summary Observation study comparing patient symptoms of bloating, pain, and nausea between CO2 insufflation vs. O2 insufflation in anterograde balloon enteroscopy.
Detailed Description

Study Subjects:

Patients >18 years of age who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde or retrograde balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures. Patients excluded from the study are those who wish not to participate, pregnant patients, mentally disabled individuals, prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or those patients deemed too high risk to undergo balloon endoscopy. High risk patients will be defined as have 3 or more of the following risk factors: chronic obstructive pulmonary disease, renal failure, morbid obesity (BMI > 40), immunosuppression, acquired/concurrent infection, diabetes, and chronic steroid use. Pre-operative risk will also be assessed by Dr. Dodig and GI fellow. ASA classifications will be evaluated on every patient by St. Joseph's staff anesthesiologist. Given that the patient is receiving general anesthesia, it is hospital policy that they are evaluated at the hospital by anesthesia team prior to the procedure for assessment of risk. Should a patient elect not to participate in the study they will receive the standard of care.

Subject Recruitment/Screening/Consent:

Patients will be recruited/consented/randomized by the GI fellow and advanced anterograde balloon endoscopist during the patient's routine office visit to discuss their pending procedure. This will take place in a private consultation room to ensure privacy and should take approximately 10-15 minutes. In order to minimize coercion, it will be made very clear to patients that their participation is voluntary and that participation will in no way affect their future care. Randomization will be performed using a sealed envelope system. All patients are to receive a copy of the informed consent.

Study Procedures:

The single balloon enteroscopy is performed with Olympus (SIF-Q180) and operated by a single experienced endoscopist, Dr. Milan Dodig, with over 1,000 single balloon endoscopies have been performed. Additional assistance provided via 3 gastroenterology fellows (Ryan Carbaugh D.O., Thomas Geisler D.O., and Justin Cochran D.O.). All anterograde enteroscopy procedures are to be performed in the surgical suite with general anesthesia. Patient CO2 levels will be non-invasively monitored by anesthesia with End-Tidal Carbon Dioxide (ETCO2). Anesthesia will be administered at the discretion of the consulting anesthesiologist via fentanyl, versed, and propofol. Insufflation utilized during procedure determined via randomization to air or carbon dioxide prior to procedure. The rate of air or carbon dioxide (level) is left to discretion of acting endoscopists for proper insufflation of bowel to achieve adequate luminal views. CO2 insufflator to be used is a Stratus CO2 insufflator made by Medivators.

After completion of procedure determination of patient pain level will be assessed at 15 minutes, 30 minutes, and 1-hour and 24-hour intervals using a patient survey. Pain is assessed based on the horizontal assessment scale (HAS). This scale based on a horizontal line measuring 100mm in length. Patient will be asked at the afore mentioned time intervals to mark with pen their level of pain on the HAS. The mark will then be measured in millimeters to determine score of pain. Score will be in a range from 0 to 100mm. Zero being no pain at all and 100mm the maximum pain level. The HAS is then documented with type of insufflation utilized and time interval. Patient will also be asked about nausea, abdominal fullness, and bloating after procedure to be ranked on a 0 to 10 scale, with zero being nothing to 10 as severe. This will also be ascertained at 15 minutes, 30 minutes, 1 hours and 24 hours. The 24 hours assessment for pain as well as dyspepsia symptoms is achieved through patients receiving HAS scale along with a questionnaire asking to rank dyspeptic symptoms. The HAS scale and dyspeptic questionnaire will be marked with patient identification number. A self-address envelope with postage will be given to patient with instruction return once completed within 24 hours of original procedure. Instruction sheets along with how to take dyspeptic survey will also be given.

Statistical Methods:

Data will be entered into Microsoft Excel 2017 and SPSS version 22 statistical programs. Analysis will include descriptive statistics, t-test, standard error, Pearson and fisher exact test. Statistical significance will be established with an alpha of 0.05 for all comparisons.

Adverse Events:

Risks consist of those entailed with general anesthesia and single balloon endoscopy.

The risk of CO2 insufflation consists of respiratory depression and CO2 embolism.16

Recording of Adverse Events:

At each contact with the subject, the investigator will seek information on adverse events by specific questioning and, as appropriate, by examination. Information on all adverse events will be recorded immediately (e.g., signs, symptoms, abnormal diagnostic procedures). The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.

Reporting of Serious Adverse Events Reports of all serious adverse events (including follow-up information) will be submitted to the St. Elizabeth's Mercy Health IRB within five business days.

Data Management and Confidentiality Patient data will be entered into electronic spreadsheets. The spreadsheet will be stored as separate file, protected by unique passwords. Only the investigators will have access to the files and their passwords. Paper records will be stored in hard copy in a locked filing cabinet in the investigator's office or at the hospital's endoscopy suit. Should any new significant findings be made during the study, the patient will be made privy to these findings in a timely manner.

Provisions to Protect the Privacy Interests of Subjects Patient consent and all other research related activities will take place in a private exam room. Patient will also be receiving a copy of their informed consent.

Funding Source:

No funding is being sought for this study or being received.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients >18 years of age who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde or retrograde balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures. Patients excluded from the study are those who wish not to participate, pregnant patients, mentally disabled individuals, prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or those patients deemed too high risk to undergo balloon endoscopy.
Condition
  • Carbon Dioxide Insufflation
  • Anterograde Single Balloon Enteroscopy
Intervention
  • Other: carbon dioxide insufflation
    Receives CO2 insufflation
  • Other: Air insufflation
    Receives air insufflation
Study Groups/Cohorts
  • Carbon Dioxide Insufflation
    Received CO2 insufflation during procedure
    Intervention: Other: carbon dioxide insufflation
  • Air Sufflation
    Received ambient insufflation during procedure
    Intervention: Other: Air insufflation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: January 17, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde single balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures.

Exclusion Criteria:

  • Those who wish not to participate, pregnant patients, mentally disabled individuals, prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or those patients deemed too high risk to undergo balloon endoscopy. High risk, defined as have 3 or more of the following risk factors: chronic obstructive pulmonary disease, renal failure, morbid obesity (BMI > 40), immuno-suppression, acquired/concurrent infection, diabetes, and chronic steroid use.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03811522
Other Study ID Numbers NEOGastro
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party North Eastern Ohio Gastroenterology and Endoscopy center
Study Sponsor North Eastern Ohio Gastroenterology and Endoscopy center
Collaborators Mercy Health Ohio
Investigators
Principal Investigator: Thomas Geisler, D.O. North Eastern Ohio Gastroenterology and Endoscopy center
PRS Account North Eastern Ohio Gastroenterology and Endoscopy center
Verification Date February 2019